BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 12057394 · Received June 23, 2021

    Report

    Report Number
    MW5102073
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 1, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INBOUND, PATIENT REPORTED CASSETTE CRACKED WITH LAST AMOUNT OF DILUENT WAS ADDED, LOT NUMBER WAS 4072210. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949016 CADD CASSETTE 100ML W/FLOWSTOP SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 4072210

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR